Observed values and change from baseline in EEGs in patients post study drug administration
A Study to Assess the Electrophysiology, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Response Using Magnetic Resonance Imaging of SAGE-718 Using a Ketamine Challenge in Healthy Subjects
Brief Summary
This study is a phase 1, double-blind, placebo-controlled crossover study of SAGE-718 using a ketamine challenge, to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamic response using magnetic resonance imaging in healthy subjects
Intervention / Treatment
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SAGE-718 (DRUG)SAGE-718 in combination with Ketamine
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Placebo (DRUG)Placebo in combination with Ketamine
Condition or Disease
- Healthy Volunteer
Phase
Study Design
| Study type: | INTERVENTIONAL |
|---|---|
| Status: | Completed |
| Study results: | No Results Available |
| Age: | 18 Years to 65 Years |
| Enrollment: | 19 (ACTUAL) |
| Funded by: | Industry |
| Allocation: | Randomized |
| Primary Purpose: | Basic Science |
MaskingQUADRUPLE:
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Clinical Trial Dates
| Start date: | Nov 12, 2018 | ACTUAL |
|---|---|---|
| Primary Completion: | Mar 08, 2019 | ACTUAL |
| Completion Date: | Mar 22, 2019 | ACTUAL |
| Study First Posted: | Dec 10, 2018 | ACTUAL |
| Results First Posted: | Aug 31, 2020 | |
| Last Updated: | Jan 20, 2022 |
Sponsors / Collaborators
Participant Groups
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No description provided
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No description provided
Eligibility Criteria
| Sex: | All |
|---|---|
| Minimum Age: | 18 |
| Maximum Age: | 65 |
| Age Groups: | Adult / Older Adult |
| Healthy Volunteers: | Yes |
Inclusion Criteria:
1. Subject is willing and able to provide 2 forms of identification; at least 1 must have a photo.
2. Subject has a body weight ≥50 kg and body mass index ≥18.0 and ≤30.0 kg/m2 at screening.
3. Subject is healthy with no history or evidence of clinically relevant medical disorders as determined by the Investigator.
Exclusion Criteria:
1. Subject has a history or presence of any psychiatric disease or condition including suicidal ideation or behavior, has answered YES to any question on the C-SSRS at screening or admission, or is currently at risk of suicide in the opinion of the Investigator
2. Subject has a history or presence of a neurologic disease or condition, including but not limited to epilepsy, closed head trauma with clinically significant sequelae, or a prior seizure.
3. Subject has a family history of epilepsy.
4. Subject has evidence of any metal in the body that may be contraindicated for receiving an MRI. This includes, but is not limited to: cardiac pacemaker, surgical implants, previous accident resulting in metal or shrapnel lodged internally, tattoos inked with metallic dyes, or a history of metal work without using protective eyewear.
5. Subject has claustrophobia or a history of claustrophobia.
6. Subject is unable or unwilling to remove piercings and/or jewelry that contain metal.
1. Subject is willing and able to provide 2 forms of identification; at least 1 must have a photo.
2. Subject has a body weight ≥50 kg and body mass index ≥18.0 and ≤30.0 kg/m2 at screening.
3. Subject is healthy with no history or evidence of clinically relevant medical disorders as determined by the Investigator.
Exclusion Criteria:
1. Subject has a history or presence of any psychiatric disease or condition including suicidal ideation or behavior, has answered YES to any question on the C-SSRS at screening or admission, or is currently at risk of suicide in the opinion of the Investigator
2. Subject has a history or presence of a neurologic disease or condition, including but not limited to epilepsy, closed head trauma with clinically significant sequelae, or a prior seizure.
3. Subject has a family history of epilepsy.
4. Subject has evidence of any metal in the body that may be contraindicated for receiving an MRI. This includes, but is not limited to: cardiac pacemaker, surgical implants, previous accident resulting in metal or shrapnel lodged internally, tattoos inked with metallic dyes, or a history of metal work without using protective eyewear.
5. Subject has claustrophobia or a history of claustrophobia.
6. Subject is unable or unwilling to remove piercings and/or jewelry that contain metal.
Primary Outcomes
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Change in glutamate and glutamine (GLX) in the anterior cingulate cortex (ACC), hippocampus, and pons as measured with magnetic resonance spectroscopy (MRS) Between Day 1 and Day 11
Secondary Outcomes
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Change in glutamate in the ACC, hippocampus, and pons, as measured with MRS Between Day 1 and Day 11
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Safety and tolerability of SAGE-718 alone and in combination with ketamine, as assessed by incidence of adverse events (AEs)/serious AEs (SAEs) Between Baseline and Day 27
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Observed values and change from baseline in ECGs in patients post study drug administration
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Safety and tolerability of SAGE-718 alone and in combination with ketamine, as assessed by Columbia-Suicide Severity Rating Scale (C-SSRS) Between Baseline and Day 27
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Safety and tolerability of SAGE-718 alone and in combination with ketamine, as assessed by Brief Psychiatric Rating Scale (BPRS) Between Baseline and Day 27
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Safety and tolerability of SAGE-718 alone and in combination with ketamine, as assessed by Clinician Administered Dissociative State Scale (CADSS) Between Baseline and Day 27
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Safety and tolerability of SAGE-718 alone and in combination with ketamine, as assessed by Observer's Assessment of Alertness and Sedation (OAAS) Between Baseline and Day 27
More Details
| NCT Number: | NCT03770780 |
|---|---|
| Other IDs: | 718-EXM-102 |
| Study URL: | https://clinicaltrials.gov/study/NCT03770780 |
Last updated: Sep 29, 2023